Lack of Effectiveness of the 23-Valent Polysaccharide Pneumococcal Vaccine in Reducing All-Cause Pneumonias Among Healthy Young Military Recruits: A Randomized, Double-Blind, Placebo-Controlled Trial
NAVAL HEALTH RESEARCH CENTER SAN DIEGO CA
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Streptococcus pneumoniae infections have periodically caused significant morbidity and outbreaks among military personnel, especially trainees. This study evaluated the effectiveness of the 23-valent polysaccharide pneumococcal vaccine PPV23 in reducing pneumonia in healthy military trainees. From 2000-2003, 152,723 military trainees from 5 US training camps were enrolled in a double-blind, placebo-controlled trial of PPV23. Participants were closely monitored during basic training for radiographically confirmed pneumonia etiology and loss-of-training days. Participants were also followed using electronic medical encounter data until 1 June 2007 for three additional outcomes any-cause pneumonia, any acute respiratory disease, and meningitis. Results Comparison of demographic data by study arm suggested the randomization procedures were sound. During basic training, 371 study participants developed radiographically confirmed pneumonia. None had evidence of S. pneumoniae infection, but other etiologies included adenovirus 38, Chlamy-dophila pneumoniae 9, and Mycoplasma pneumoniae 8. During the follow-up period, many study participants, in both the vaccine and placebo groups, had clinical encounters for the medical outcomes of interest. However, Coxs proportional hazard modeling revealed no evidence of a protective vaccine effect during recruit training radiographically confirmed pneumonia or up to 6.7 years after enrollmentany-cause pneumonia, any acute respiratory disease, or meningitis. Data from this large, double-blind, placebo controlled trial do not support routine use of PPV23 among healthy new military trainees. This clinical trial was registered at clinical-trials.gov registration number NCT02079701.
- Anatomy and Physiology
- Medicine and Medical Research
- Military Forces and Organizations